Aims In total knee arthroplasty (TKA), blood loss continues internally after surgery is complete. Typically, the total loss over 48 postoperative hours can be around 1,300 ml, with most occurring within the first 24 hours. We hypothesize that the full potential of tranexamic acid (TXA) to decrease TKA blood loss has not yet been harnessed because it is rarely used beyond the intraoperative period, and is usually withheld from ‘high-risk’ patients with a history of thromboembolic, cardiovascular, or cerebrovascular disease, a patient group who would benefit greatly from a reduced blood loss. Methods TRAC-24 was a prospective, phase IV, single-centre, open label, parallel group, randomized controlled trial on patients undergoing TKA, including those labelled as high-risk. The primary outcome was indirect calculated blood loss (IBL) at 48 hours. Group 1 received 1 g intravenous (IV) TXA at the time of surgery and an additional 24-hour postoperative oral regime of four 1 g doses, while Group 2 only received the intraoperative dose and Group 3 did not receive any TXA. Results Between July 2016 and July 2018, 552 patients were randomized to either Group 1 (n = 241), Group 2 (n = 243), or Group 3 (n = 68), and 551 were included in the final analysis. The blood loss did differ significantly between the two intervention groups (733.5 ml (SD 384.0) for Group 1 and 859.2 ml (SD 363.6 ml) for Group 2; mean difference -125.8 ml (95% confidence interval -194.0 to -57.5; p < 0.001). No differences in mortality or thromboembolic events were observed in any group. Conclusion These data support the hypothesis that in TKA, a TXA regime consisting of IV 1 g perioperatively and four oral 1 g doses over 24 hours postoperatively significantly reduces blood loss beyond that achieved with a single IV 1 g perioperative dose alone. TXA appears safe in patients with history of thromboembolic, cardiovascular, and cerebrovascular disease. Cite this article: Bone Joint J 2021;103-B(10):1595–1603.
Background Hyponatraemia, defined as a serum sodium [Na] concentration below 135 mmol/L, is common following surgery. As inpatient peri-operative stays shorten, there is a need to recognise pre-operative risk factors for post-operative hyponatraemia and complications associated with a peri-operative drop in Na. This audit aimed to investigate the prevalence of, risk factors for, and complications associated with hyponatraemia following elective primary hip and knee arthroplasty. Methods Data were collected within a retrospective audit of inpatient complications and unplanned reattendance or readmission at hospital in consecutive elective primary hip and knee arthroplasty patients in a single high throughput elective primary joint unit. The hospital’s electronic database identified 1000 patients who were admitted electively between February 2012 and June 2013 under the care of a single consultant orthopaedic surgeon for either total hip arthroplasty, total knee arthroplasty, or uni-compartmental knee arthroplasty. Groups were compared using appropriate tests, including chi-square analysis (or Fisher’s exact test), Mann-Whitney U test, Kruskal-Wallis test, and Wilcoxin signed-rank test. Logistic regression analysis was used to determine factors associated with hyponatraemia. Results Of the total 1000 patients, 217 (21.7%) developed post-operative hyponatraemia. Of these, 177 (81.6%) had mild (Na 130–134 mmol/L), 37 (17.1%) had moderate (Na 125–129 mmol/L), and 3 (1.4%) had severe (Na < 125 mmol/L) hyponatraemia. In multivariate analysis, age, pre-operative Na, and fasting glucose on day 1 remained significantly associated with having hyponatraemia post-operatively. There were no significant differences in reattendance at emergency departments and/or readmission within 90 days between those who had post-operative hyponatraemia whilst in hospital (39/217 = 18.0%) and those who did not (103/783 = 13.2%), or between those who were discharged with hyponatraemia (18/108 = 16.7%) and those discharged with normal Na (124/880 = 14.1%). Conclusion Approximately one fifth of elective joint arthroplasty patients had post-operative hyponatraemia. In these patients, older age, lower pre-operative Na and higher fasting glucose predicted post-operative hyponatraemia. We found no evidence that those discharged with hyponatraemia had more reattendance at emergency departments or readmission to hospital. We suggest that otherwise well patients with mild hyponatraemia can safely be discharged and followed up in the community.
BackgroundWhile it is has been proven that tranexamic acid (TXA) reduces blood loss in primary total hip and knee arthroplasty (THA and TKA), there is little published evidence on the use of TXA beyond 3 h post-operatively. Most blood loss occurs after wound closure and the primary aim of this study is to determine if the use of oral TXA post-operatively for up to 24 h will reduce calculated blood loss at 48 h beyond an intra-operative intravenous bolus alone following primary THA and TKA. To date, most TXA studies have excluded patients with a history of thromboembolic disease.Methods/designThis is a phase IV, single-centred, open-label, parallel-group, randomised controlled trial. Participants are randomised to one of three groups: group 1, an intravenous (IV) bolus of TXA peri-operatively plus oral TXA post-operatively for 24 h; group 2, an IV bolus of TXA peri-operatively or group 3, standard care (no TXA). Eligible participants, including those with a history of thromboembolic disease, are allocated to these groups with a 2:2:1 allocation ratio. The primary outcome is the indirectly calculated blood loss 48 h after surgery. Researchers and patients are not blinded to the treatment; however, staff processing blood samples are. Originally 1166 participants were required to complete this study, 583 THA and 583 TKA. However, following an interim analysis after 100 THA and 100 TKA participants had been recruited to the study, the data monitoring ethics committee recommended stopping group 3 (standard care).DiscussionTRAC-24 will help to determine whether an extended TXA dosing regimen can further reduce blood loss following primary THA and TKA. By including patients with a history of thromboembolic disease, this study will add to our understanding of the safety profile of TXA in this clinical situation.Trial registrationISRCTN registry, ISRCTN58790500. Registered on 3 June 2016, EudraCT: 2015–002661-36.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2784-3) contains supplementary material, which is available to authorized users.
Background Post-operative hyponatraemia is common following arthroplasty. Clinical hyponatraemia guidelines lack detail on when treatment is necessary, and there is a paucity of literature to guide best practice. Methods Data were collected within retrospective service evaluations over two time periods in a single high throughput joint unit. The hospital’s electronic database identified 1000 patients who were admitted electively between February 2012 and June 2013 and again between November 2018 and April 2019 for primary total hip, total knee or uni-compartmental knee arthroplasty. Hyponatraemia and non-hyponatraemia groups were compared. Logistic regression analysis was used to identify independent predictors of post-operative hyponatraemia, length of stay (LOS), re-attendance or re-admission to hospital. Results Between 2012–2013 and 2018–2019, 32.1% and 25.7% of patients, respectively, developed post-operative hyponatraemia (serum sodium (s[Na]) ≤135 mmol/L). Those with post-operative hyponatraemia were significantly older, weighed less, were more comorbid and had lower pre-operative sodium. Multivariate analysis showed that increased age, knee surgery and lower pre-operative s[Na] independently predicted post-operative hyponatraemia. Post-operative hyponatraemia did not independently predict LOS, re-attendance or re-admission to hospital, within 90 days, in either cohort. Conclusion Post-operative hyponatraemia is common and may be a marker of pre-operative vulnerability. In these cohorts, it was not independently associated with LOS, re-attendance or re-admission to hospital. We suggest that otherwise well patients with mild hyponatraemia can be safely discharged earlier than is often the case and may not require extensive investigation. Further examination and research is required to develop a pre-operative approach to predict which patients will develop significant post-operative hyponatraemia.
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